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High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136448
First Posted: August 29, 2005
Last Update Posted: March 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
August 25, 2005
August 29, 2005
March 10, 2011
February 1993
September 2007   (Final data collection date for primary outcome measure)
The primary purpose of this study is to evaluate the ability of IL-2 to generate cytotoxic and inhibitory activity against cryopreserved autologous leukemic myeloblasts obtained at the time of diagnosis.
Same as current
Complete list of historical versions of study NCT00136448 on ClinicalTrials.gov Archive Site
  • To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C
  • To assess additional immunologic effects of IL-2
  • To obtain preliminary data regarding the rate of disease relapse
  • To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C
  • To assess additional immunologic effects of IL-2
  • To obtain preliminary data regarding the rate of disease relapse.
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High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)
High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.

Patients will receive standard remission induction therapy with daunorubicin at a dose of 45 mg/m2/day for 3 days and continuous infusion cytarabine at a dose of 200 mg/m2/day for 7 days.

Those patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mg/m2 every 12 (q12) hours on days 1, 3 and 5 (total of 6 doses).

Patients who are still in remission will receive interleukin-2 (IL-2) upon count recovery at a dose of 8.1 X 10^5 U/m2/day by continuous infusion for 10 weeks. In addition, patients will receive bolus IL-2 at a dose of 6 X 10^5 U/m2 by intravenous bolus weekly for 6 doses through day 63.

Patients will be seen on a weekly basis while on treatment for examination and bloodwork.

At the end of treatment, patients will have a physical exam and bloodwork performed monthly for two years, then 4 times per year for two years.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Acute Myelogenous Leukemia
  • Drug: cytosine arabinoside (ara-C)
  • Drug: daunomycin
  • Drug: interleukin-2
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have AML based on French-American-British (FAB) criteria.
  • Patients must have a total bilirubin of < 2.0 mg/dL, SGOT < 90 IU/mL, alkaline phosphatase < 250 U/mL and a serum creatinine < 2.0 mg/dL.
  • Age 18 years or greater.

Exclusion Criteria:

  • History of an antecedent hematologic malignancy such as myelodysplastic syndromes (MDS).
  • Uncontrolled infection.
  • History of a previous or concomitant malignancy other than non-melanoma skin cancer.
  • Evidence of central nervous system (CNS) leukemia.
  • Current use of corticosteroids.
  • Prior treatment for AML, other than hydroxyurea.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00136448
92-148
Not Provided
Not Provided
Not Provided
Not Provided
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP